BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION 4000

    MDR report key: 800277 · Received December 22, 2006

    Report

    Report Number
    1061857-2006-00229
    Event Type
    Injury
    Date Received
    December 22, 2006
    Date of Event
    November 27, 2006
    Report Date
    November 27, 2006
    Manufacturer
    ALCON LABORATORIES IRELAND LTD. ALCON - ORLANDO TECHNOLOGY CTR
    Product Code
    LZS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGERY DATABASE PERFORMANCE VERIFICATION WAS CONDUCTED ON THIS SYSTEM AND DETERMINED THE LASER PERFORMANCE FACTORS ANALYZED WERE OPERATING WITHIN SPECIFICATION. DETERMINATION OF ROOT CAUSE. ASSESSMENT: THE CONCLUSION OF THE DEVICE INVESTIGATION INDICATES THE SYSTEM PERFORMED WITHIN SPECIFICATIONS DURING THIS PATIENT'S SURGERY. NON-PRODUCT FACTORS INCLUDING PATIENT RESPONSE TO THE LASER ABLATION, PATIENT HEALING CHARACTERISTICS AND PREOPERATIVE PATIENT SELECTION COULD NOT BE REVIEWED AS THE SURGEON DECLINED TO PROVIDE ANY PATIENT INFORMATION. CONCLUSION: BASED ON THE RESULTS OF THE INVESTIGATION OF PRODUCT AND NON-PRODUCT FACTORS, THE DEVICE WAS NOT FOUND TO BE A CONTRIBUTOR TO THE REPORTED OVERCORRECTION. HOWEVER, THE NON-PRODUCT RELATED FACTORS MENTIONED ABOVE COULD NOT BE RULED OUT AND MAY HAVE BEEN CONTRIBUTORS.

    Description of Event or Problem · 1

    A SYSTEMS OPERATOR REPORTS 5 PATIENT'S WITH OVERCORRECTIONS FOLLOWING LASIK SURGERY. THE SURGEON DECLINED TO PROVIDE ANY PATIENT INFORMATION, SO THE AMOUNT OF THE OVERCORRECTIONS IS NOT KNOWN. THIS PATIENT IS BEING REPORTED UNDER MANUFACTURER'S REPORT #1061857-2006-00229. THE OTHER 4 PATIENT'S ARE BEING REPORTED UNDER MANUFACTURER'S REPORT #: 1061857-2006-00227, 1061857-2006-00228, 1061857-2006-00230, 1061857-2006-00231.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM LZS ALCON LABORATORIES IRELAND LTD. ALCON - ORLANDO TECHNOLOGY CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other